Summary

The rate of adolescent extreme obesity is rapidly rising, and impacting quality of life,
psychosocial situation, and health of the affected youth. However, as few of these
adolescents seek medical care, little is known about the longitudinal course of adolescent
extreme obesity.

In this study, the investigators aim to provide structured care for adolescents with obesity
and extreme obesity over a prolonged period of time, and to gain information on the course
of obesity and the success of different treatment options. The study is a subproject of the
"Medical and psychosocial implications of adolescent extreme obesity - acceptance and
effects of structured care", short: "Youth with Extreme obesity Study (YES)", which aims at
improving the medical care and social support structures for youth with obesity and extreme
obesity in Germany. Obese youth and young adults (BMI ≥ 30kg/m2) between the ages of 14 and
24.9 years (initially up to 21 years) are eligible to participate. Participants will have a
physical check-up every 12 months (initially every 6 months), complete questionnaires on
their health, socioeconomic status and wellbeing, and are offered blood test and diagnostic
procedures to assess comorbidities. Participants are offered support and guidance for social
and vocational integration. The study will evaluate and inform treatment and support options
for adolescents with extreme obesity.

Eligibility Criteria

Additional Information

Course of Obesity and Extreme Obesity in Adolescents, in the Context of Different Treatment Options - a Longitudinal Prospective Observation Study

Principal investigator

Susanna Wiegand, Dr. med.

Description

Little is known about the longitudinal course of adolescent extreme obesity. In this
multicenter study, the investigators aim to enroll adolescents with extreme obesity (BMI ≥
35kg/m2) in a 9 year longitudinal, prospective observation that will reveal information on
the course of obesity and the success of different treatment options. Adolescents with more
moderate degrees of obesity (BMI 30-34,9kg/m2) will serve as a control group. The project
builds on the Consortium "Medical and psychosocial implications of adolescent extreme
obesity - acceptance and effects of structured care", short: "Youth with extreme obesity
Study (YES)", which comprises the recruitment and characterization of obese youth from
different healthcare- and non healthcare settings, a randomized controlled trial to
investigate a novel intervention targeted at improving quality of life and social
functioning of extremely obese adolescents, a structured prospective evaluation of
adolescent bariatric surgery, and economic assessments of the financial burden of extreme
adolescent obesity on the healthcare system.
Based on the current state of knowledge, the investigators have formulated the following a
priori hypotheses in regards to the longitudinal observation study:
1. Youth with extreme obesity (BMI ≥ 35kg/m2) achieve lower adherence with the structured
care program compared to adolescents with more moderate degrees of obesity (BMI
30-34,9kg/m2).
2. Youth with extreme obesity (BMI ≥ 35kg/m2) are less likely to achieve and sustain
weight loss over a prolonged period of time, compared to adolescents with more moderate
degrees of obesity (BMI 30-34,9kg/m2).
3. Youth with extreme obesity (BMI ≥ 35kg/m2) are harder to integrate in the job market
compared to youth with more moderate degrees of obesity (BMI 30-34,9kg/m2).
4. Youth with extreme obesity (BMI ≥ 35kg/m2) have higher incidence and severity of
co-morbidities compared to youth with more moderate degrees of obesity (BMI
30-34,9kg/m2).
The investigators aim to recruit a total of 600 adolescents age 14 to 24.9 years (initial
age up to 21 years; changed in an amendment in February 2013) with extreme obesity (BMI ≥ 35
kg/m2) and 600 adolescents with obesity (BMI 30-34.9 kg/m2) over a 24 months period. The
five participating university centers are distributed across 4 geographic regions in the
North (Berlin), in the West (Essen/Datteln), in the East (Leipzig) and in the South (Ulm) of
Germany, and will therefore render data that are representative of Germany as a whole.
Adolescent will be examined annually (initially examinations were biannually, this was
changed in an amendment in December 2014), and testing will include an array of standardized
questionnaires and validated instruments to assess health, psycho-social situation,
psychiatric co-morbidities and health related quality of life, as well as a physical
examination, laboratory tests, and screenings for orthopedic co-morbidities and sleep apnea.
Participants are offered support and guidance in regards to social and vocational
integration with the aim of improving self esteem and social functioning. Data will be
entered in an extended version of the "German National Register for Longitudinal Research on
Childhood Obesity". We will perform sub-analyses based on the treatment options these youths
have followed The project will reveal the acceptance and outcomes of a structured healthcare
program for adolescents with extreme obesity and provide unique information on the medical
and psychosocial development of adolescents with extreme obesity in Germany.

Trial information was received from ClinicalTrials.gov and was last updated in September 2015.